An Antibody-armored Dendritic Cell in Patients With Solid Tumors (dendritic cell)

Shanghai Cell Therapy Group

Status and phase

Enrolling

Phase 1

Conditions

Solid Cancers

Adjuvant Therapy

Treatments

Biological: Armored Dendritic Cell Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT07479667

JL104-A-01

Details and patient eligibility

About

This study is a single-arm, open-label, single-administration dose-escalation study.

Enrollment

8 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 18 to 80 years, body weight ≥ 40 kg; male or female, no gender restriction;
ECOG performance status score of 0 to 1;
Histopathologically confirmed solid tumors including pancreatic cancer, colorectal cancer (CRC), gastric cancer and other such malignancies;
Having undergone R0 or R1 resection with completion of at least 4 cycles of standard postoperative adjuvant chemotherapy;
Positive expression for at least one of TERT, P53, KRAS and Survivin;
Sufficient venous access with no contraindications to peripheral blood mononuclear cell collection;
Adequate organ and bone marrow function:
a) Platelet count ≥ 90×10⁹/L;
b) Hemoglobin ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days);
c) Mononuclear cell count ≥ 1.0×10⁹/L;
d) International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × upper limit of normal (ULN);
e) Serum creatinine ≤ 1.5 × upper limit of normal (ULN);
f) Aminotransferases (AST, ALT) ≤ 2.5 × upper limit of normal (ULN);
g) Total bilirubin ≤ 2 × upper limit of normal (ULN);
h) Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as assessed by echocardiography within 1 month prior to enrollment;
Able to understand the study requirements and considerations and provide informed consent to participate in the clinical study in accordance with the study requirements
Subjects agree to use effective contraceptive measures for at least 6 months following dendritic cell (DC) injection.

Exclusion criteria

Women who are pregnant or breastfeeding;
Positive for human immunodeficiency virus (HIV) antibody or syphilis antibody; positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (anti-HBc) or hepatitis B e antibody (anti-HBe) with hepatitis B virus (HBV) DNA copy number above the lower limit of detection (LLOD) or ≥ 1000 copies/mL; or hepatitis C virus (HCV) RNA copy number above the LLOD;
Prior treatment with any dendritic cell (DC) or other immune cell therapy;
History of hypersensitivity to immunotherapy and related drugs, or history of severe allergic reactions;
Uncontrolled active infection;
Subjects with active autoimmune disease receiving relevant treatment; subjects with organ transplantation who are still on immunosuppressive agents; or subjects requiring long-term use of immunosuppressive agents (> 15 mg/day prednisone or equivalent glucocorticoid dose) and who have used them within 4 weeks prior to screening;
Presence of central nervous system (CNS) metastases and clinically significant CNS diseases;
Received systemic anti-tumor therapy within 4 weeks prior to screening;
Presence of residual lesions or unremoved foci on screening examinations (post-adjuvant chemotherapy / post-surgery), with imaging indicating local recurrence or confirmed distant metastasis;
History of other active malignancies within 5 years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.);
Clinically significant major cardiovascular diseases including:
a) Symptomatic congestive heart failure
b) Unstable angina pectoris
c) Severe arrhythmia requiring pharmacotherapy
d) Uncontrolled hypertension
e) Myocardial infarction or ventricular arrhythmia within 6 months prior to screening;
Any other conditions deemed by the investigator to render the subject ineligible for participation in the clinical study